Name: The Pharmaceutical Regulatory Process
SKU: 55618473
Price: 132.25 EUR
Availability: InStock
Author: Berry, Ira R. ; Martin, Robert P.

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portada The Pharmaceutical Regulatory Process

Type

Physical Book

Publisher

CRC Press

Author

Berry, Ira R. ; Martin, Robert P.

Language

English

Pages

492

Format

Paperback

ISBN13

9781138381285

Edition No.

0002

Synopsis "The Pharmaceutical Regulatory Process"

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, and FDA regulators, it includes policies and procedures that pharmaceutical companies need to implement regulatory compliance post-approval.New chapters cover: the marketing of unapproved new drugs and FDA efforts to keep them in regulatory compliance pharmacovigilance programs designed to prevent widespread safety issues legal issues surrounding the sourcing of foreign APIs the issues of counterfeit drugs updates on quality standards

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The Pharmaceutical Regulatory Process - Berry, Ira R. ; Martin, Robert P.

Synopsis "The Pharmaceutical Regulatory Process"

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